Promus Element, Element Plus Receive CE Mark Update to Include Three-Month Dual Antiplatelet Therapy


November 9, 2012
Boston Scientific Promus Element Plus Promus Element Drug Eluting Stent

November 9, 2012 — Boston Scientific Corp. has received approval to update the directions for use (DFU) labeling for Promus Element and Promus Element Plus coronary drug eluting stent (DES) systems to include three-month dual antiplatelet therapy (DAPT). This language outlines a minimum duration of three months of DAPT for certain patients who may need to interrupt or discontinue the medication for a variety of reasons and supports the strong safety profile for Promus Element and Promus Element Plus stents. The label change will be introduced in CE mark countries.

"Boston Scientific is pleased to provide this additional guidance in our labeling," said Keith D. Dawkins, M.D., executive vice president and global chief medical officer for Boston Scientific. "However, it remains important to consider the major clinical society guidelines for DAPT post-stent implantation for durable polymer stents."

Current European of Cardiology (ESC) guidelines recommend nine to 12 months of DAPT, with a minimum of six months for those who received a DES. The American Heart Association (AHA) and American College of Cardiology (ACC) recommend up to 12 months of DAPT for DES post-stent implantation.

"This update to our labeling highlights that the need still exists for a drug-eluting stent that reduces the risks associated with long-term durable polymer exposure," said Kevin Ballinger, president of the interventional cardiology division at Boston Scientific. "We believe our next-generation Synergy stent, with its unique PLGA bioabsorbable polymer, will address that need."

The Synergy stent is unique in that its proprietary PLGA polymer and everolimus drug coating dissipate by three months. This simultaneous drug and polymer absorption is designed to encourage optimal healing, eliminate long-term polymer exposure and potentially lead to reduced long-term events, such as very late stent thrombosis.

The Synenergy stent is an investigational device, limited by law to investigational use, and is not approved or available for sale in the United States and Europe. 

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